Device Classification Name |
Otoscope
|
510(k) Number |
K781029 |
Device Name |
OTOSCOPE, DIAG. MODELS 20100 & 20200 |
Applicant |
WELCH ALLYN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WELCH ALLYN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 06/19/1978 |
Decision Date | 06/28/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|